SBIR Phase II: Novel Treatment for Stress Urinary Incontinence

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the expedited development of a novel non-surgical medical device and therapeutic treatment for the approximately 1 in 3 women over the age of 30 who suffer from urinary incontinence, two thirds of whom, in part due to notable deficiencies of available solutions, elect to live without treatment while their symptoms progressively worsen. Urinary incontinence, although a very private concern, has far-reaching physical, psychological, social, and economic implications. For example, urinary incontinence has been found to reduce health-related quality of life measures on par with depression, incontinence is the number one reason for admittance into nursing homes, and the annual cost to the US healthcare system is estimated at $25 billion. Through design and validation activities this project will demonstrate the functionality of a wearable device that provides discreet, comfortable, easy-to-use therapy for female stress urinary incontinence. The technological understanding gained through this work lays the groundwork for subsequent commercialization of an FDA cleared product that will enhance the lives of tens of millions of American women. The proposed project provides a new framework for wearable therapeutics by enabling the patient to treat incontinence via discreet surface electrical stimulation without interruption to daily activity. Current non-surgical care often involves electrical stimulation via intravaginal probe, a treatment most woman are not willing to adopt or maintain. This project builds on successful Phase I feasibility work in which a contiguous array of cutaneous electrodes placed proximate the perineal tissue to deliver sufficient electrical muscle stimulation to promote pelvic floor toning were shown to maintain this efficacy under conditions associated with continuous wear. The Phase II project goal is to develop an incontinence specific electrical muscle stimulator to function with the electrode array. The system architecture will enable manipulation of the therapeutic waveform to support future multi-armed clinical studies designed to test the efficacy of various treatment regimens. The system will also track treatment frequency, duration and intensity to provide information to clinical researchers. Activity will include design, prototype fabrication, performance testing, human factors assessments, iteration and electrical safety validation. Refinements to the electrode array are also anticipated. The project will deliver a device suitable for future evaluation a human clinical studies, FDA clearance and product commercialization.